U.K. Regulator Reinstates Full GMP Status Of Indoco Remedies’ Goa Facility
The status has been updated following a full GMP inspection by the Medicines and Healthcare Products Regulatory Agency of the U.K.
Drug firm Indoco Remedies Ltd. on Friday said the U.K. health regulator has fully-reinstated the Good Manufacturing Practice status of its Goa facility.
The status has been updated following a full GMP inspection by the Medicines and Healthcare Products Regulatory Agency of the United Kingdom during May 21-23, 2019, the company said in a filing to BSE. The Inspection Action Group of the U.K. has confirmed that the GMP status of its Goa Plant I has been fully reinstated by the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, Indoco Remedies said.
With this development, the company's operations in Europe will now take off on a fast-track, Indoco Remedies MD Aditi Panandikar said. The U.K. health regulator had inspected the Goa plant I in March 2018, which resulted in the issuance of a restricted GMP certificate for medicinally critical products, Indoco Remedies said.
Subsequently, it conducted a focused audit in October 2018 and GMP audit in May 2019. These audits were completed with no critical observations and Indoco has now received a full GMP status for its Goa Plant I, it added. Goa Plant I manufactures solid dosages, liquid orals, and external preparations, Indoco Remedies said.